Platelet Concentrate Separation Kit for Celsep Centrifuge System

Q: What is the product code of K021927?

The FDA product code is LXG – Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.

FDA 510(k) K021927 · Biomet, Inc.

Substantially Equivalent

510(k) numberK021927

Submission

Device name: Platelet Concentrate Separation Kit for Celsep Centrifuge System
Applicant: Biomet, Inc.
Warsaw, IN, US
Received: June 12, 2002
Decision date: July 12, 2002
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LXG – Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class: Class I (low risk)
Regulation: 21 CFR 862.2050
Specialty: Clinical Chemistry

Other 510(k)s with product code LXG

510(k)	Device	Applicant	Decision
K943466	Mini S.F.T. (Urine Preservative)LXG · Traditional	Cambridge Diagnostic Products, Inc.	05/24/1995SE
K896802	Magnet PadLXG · Traditional	Westmark, Sterile Packing Systems, Inc. (Sps)	12/27/1989SE

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Questions and answers

When was Platelet Concentrate Separation Kit for Celsep Centrifuge System cleared by the FDA?

Platelet Concentrate Separation Kit for Celsep Centrifuge System (K021927) received a 510(k) decision of Substantially Equivalent on July 12, 2002, 30 days after the submission was received.

What is the product code of K021927?

The FDA product code is LXG – Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.